FINACEA GEL

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

AZELAIC ACID

Commercializzato da:

LEO PHARMA INC

Codice ATC:

D10AX03

INN (Nome Internazionale):

AZELAIC ACID

Dosaggio:

15%

Forma farmaceutica:

GEL

Composizione:

AZELAIC ACID 15%

Via di somministrazione:

TOPICAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0126787002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2005-09-02

Scheda tecnica

_FINACEA Product Monograph, version 1.0_
_Page 1 of 20 _
PRODUCT MONOGRAPH
PR FINACEA
®
Azelaic Acid Gel
15% w/w
Topical
Antirosacea Agent
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.ca
Submission Control No.: 229634
Date of Revision:
September 18, 2019
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
_FINACEA Product Monograph, version 1.0_
_Page 2 of 20 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
SPECIAL HANDLING INSTRUCTIONS
.........................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................10
PHARMACEUTICAL INFORMATION
................................................